Menarini Stemline · 2 days ago
Clinical Trial Associate
New York, United States
Full-time
Onsite
Entry Level
$115K/yr - $155K/yr
2+ years expMenarini Stemline is an Italian pharmaceutical company committed to creating innovative therapeutic solutions in oncology. The Clinical Trial Associate will provide operational support to Clinical Trial Teams throughout the lifecycle of clinical trials, assisting in the start-up, execution, and close-out phases.
BiotechnologyHealth CareHealth DiagnosticsOncology
Responsibilities
Acts as a central point of contact for the clinical trial team for designated project communications, correspondence, and associated documentation
Ownership and maintenance of trial SharePoint site
Ownership of electronic Trial Master File (eTMF) and maintenance of eTMF set up, organize, and maintain clinical study documentation (e.g. Trial Master File documents, email correspondence, training materials, etc.) including preparation for internal/external audits, periodic and final quality review and archival
Coordinate internal and external meeting agendas and minutes, as applicable. Responsible for preparing and distributing Clinical Trial Team (CTT) meeting agenda and capturing CTT meeting minutes
Assists the clinical trial team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the standard operating procedures
Assists with the maintenance of trial-specific tracking reports (e.g. patient enrollment, regulatory documents, site visits, Adverse Event (AE/SAE), Protocol deviations
Supports the clinical trial team(s) in updating reports and management plans
Assists in the resolution of issues, questions, and process requests for additional study supplies
May participate and support responses to Quality Assurance and/or regulatory authority inspection audits and always maintain inspection readiness
Maintains trial specific training records, including preparation of the trial team list. Collaborates with Quality Assurance to ensure all appropriate team members are trained on trial specific plans and documents
Coordinates with trial vendors throughout the clinical trial lifecycle and maintains vendor list
Participates in company improvement initiatives
Assists in coordinating of Investigator and third-party payments
Act as a backup for other Clinical Trial Associates (CTAs) as needed
Can serve as a Clinical Operations Representative
Provides updates on clinical trial status on ClinicalTrials.gov
Supports preparation of Clinical Study Report and appendices as needed
Qualification
Required
Minimum 2 years in a clinical research environment
Experience in oncology is required
B.A./B.S. in life sciences or equivalent experience
Knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements
Experience utilizing various eTMF platforms
Possess strong interpersonal, organizational, written and oral communication skills, and must be detail-oriented
Work independently to prioritize tasks and manage multiple projects while operating under tight deadlines
Capable of developing complex reports and meticulously tracking administrative documents, including correspondence
Handle sensitive and confidential information with the utmost discretion
Collaborate across different organizations and work as part of a team to support departmental initiatives
Proficient in Microsoft Suite/Office, Adobe Acrobat, and Smartsheet
Benefits
Short-Term Incentive Programs
Fidelity 401(k) (with company match)
Anthem Premier PPO and HDHP insurance plans
Company paid Basic Life & AD&D insurance
Pre-tax FSA/HSA programs
Company
Menarini Stemline
The Menarini Group ("Menarini"), a leading Italian pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc.
501-1000 employees
H1B Sponsorship
Menarini Stemline has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (2)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$195.09MKey Investors
Pequot Capital
2020-05-04Acquired
2019-08-01Post Ipo Equity· $88M
2019-01-15Post Ipo Equity· $92M
Leadership Team
David Gionco
Vice President of Finance and Chief Accounting Officer
Ahmed Rabie
Chief Commercial Officer
Recent News
2025-10-13
2025-09-27
Company data provided by crunchbase